Maintenance Therapy With Sunitinib or Observation in Metastatic Pancreatic Cancer

NCT00967603 | Completed Phase 2

• 3 other identifiers: CDR0000643632PACT-122008-000814-65
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Sunitinib malate may stop the growth of tumor cells by blocking some of the tyrosine kinases needed for angiogenesis and cell growth. It is not yet known whether sunitinib malate is effective as maintenance therapy in delaying tumor progression in patients with metastatic pancreatic cancer who are progression-free after 6 months of induction chemotherapy. PURPOSE: This randomized phase II trial is studying sunitinib malate as maintenance therapy to see how well it works compared with observation in avoiding tumor progression after induction chemotherapy in patients with metastatic pancreatic cancer.

Conditions

Pancreatic Cancer

Keywords

adenocarcinoma of the pancreas; stage IV pancreatic cancer

Outcome Measures

Primary Outcomes (1)

• 6-month progression-free survival

  CT scan

  every 2 months during therapy; every 3 months thereafter

Secondary Outcomes (8)

• Response rate

  every 2 months during therapy; every 3 months thereafter

• Toxicity

  monthly during therapy

• OVERALL SURVIVAL

  monthly

• PROGRESSION-FREE SURVIVAL

  every 2 months during therapy; every 3 months thereafter

• endothelial circulating cells

  baseline + every 2 months during therapy until progression

Study Arms (2)

observation

NO INTERVENTION

no therapy until progression

sunitinib

EXPERIMENTAL

sunitinib until progression or for a maximum of 6 months

Drug: sunitinib

Interventions

sunitinib DRUG

oral sunitinib 37.5 mg daily

Also known as: SUTENT

sunitinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Pathologically confirmed metastatic pancreatic adenocarcinoma * Stage IV disease * Received chemotherapy for a duration of 6 months * No progressive disease for ≥ 6 months since beginning of induction chemotherapy (irrespective of regimen and response: stable disease, partial response, or complete response) demonstrated by the following: * Two consecutive CT or MR scans separated by ≥ 6 weeks * Normal or no CA19.9 increase \> 20% during the last month PATIENT CHARACTERISTICS: * Karnofsky Performance Status 50-100% * Adequate bone marrow, liver, and kidney function * Normal thyroid gland function (euthyroid) * Not pregnant or nursing * No duodenal, gastric, or intestinal infiltration * Able to take oral medication * None of the following conditions related to cardiac disease, failure, or vascular disease including any of the following: * QTc interval prolongation * Congestive heart failure * Serious cardiac arrhythmias * Active coronary artery disease * Myocardial infarction * Ischemia * Cerebrovascular accident * Evidence of pre-existing uncontrolled hypertension * No other malignancies except surgically cured carcinoma in situ of the cervix, basal or squamous cell carcinoma of the skin, or other adequately treated neoplasms for which the patient has been disease-free for ≥ 5 years PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No other prior chemotherapy apart from first-line treatment for pancreatic cancer * More than 3 weeks and less than 8 weeks since prior chemotherapy (\> 1 week in the case of fluorouracil as continuous infusion or capecitabine) * No prior antiangiogenesis drugs, including any of the following: * Sunitinib malate * Sorafenib * Bevacizumab * AZD2171 * Vatalanib * VEGF trap * Pazopanib * More than 1 month since prior major surgical procedure and completely recovered * More than 7-12 days since prior and no concurrent drugs that are known CYP3A4 inhibitors * No concurrent drugs with potential anti-arrhythmic activity * No concurrent thrombolytic agent at therapeutical dose * No concurrent treatment with other experimental drugs

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

San Raffaele Scientific Institute

Milan, 20132, Italy

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Sunitinib

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Michele Reni, MD

  Istituto Scientifico H. San Raffaele

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 27, 2009
• First Posted: August 28, 2009
• Study Start: February 1, 2008
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: February 1, 2012

Record last verified: 2009-12

Locations

IT (1)